FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDLINE EXCEL WHEELCHAIRS
K Number: K990463
·
Decision Mar 15, 1999
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
11
Review Days
31
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Basic Information
- Device Name
- MEDLINE EXCEL WHEELCHAIRS
- K Number
- K990463
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medline
- Date Received
- February 12, 1999
- Decision Date
- March 15, 1999
- Product Code
- IOR
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IOR), ordered by most recent decision date.
ICON 35; ICON 45; ICON 60; ICON 30FAF
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K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
FDA 510(k)
FDA Class 1
·Physical Medicine
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